MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-07-24 for ACUFEX REAR ENTRY AIMER - RIGHT 013642 manufactured by Smith & Nephew, Inc./endoscopy Division.
[104794]
Tip of instrument broke off while in use due to excessive force. Surgeon chose not to retrieve the broken off piece, leaving it in the body. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-1998-00035 |
| MDR Report Key | 178977 |
| Report Source | 07 |
| Date Received | 1998-07-24 |
| Date of Event | 1998-06-24 |
| Date Facility Aware | 1998-06-24 |
| Date Mfgr Received | 1998-06-24 |
| Device Manufacturer Date | 1993-09-01 |
| Date Added to Maude | 1998-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUFEX REAR ENTRY AIMER - RIGHT |
| Generic Name | DRILL GUIDE |
| Product Code | HXY |
| Date Received | 1998-07-24 |
| Returned To Mfg | 1998-07-02 |
| Model Number | NA |
| Catalog Number | 013642 |
| Lot Number | 693 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174027 |
| Manufacturer | SMITH & NEPHEW, INC./ENDOSCOPY DIVISION |
| Manufacturer Address | 130 FORBES BLVD. MANSFIELD MA 02048 US |
| Baseline Brand Name | ACUFEX REAR ENTRY AIMER - RIGHT |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | 013642 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-24 |